DEPUY CAS KNEE INSTRUMENTATION

Neurological Stereotaxic Instrument

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Cas Knee Instrumentation.

Pre-market Notification Details

Device IDK043223
510k NumberK043223
Device Name:DEPUY CAS KNEE INSTRUMENTATION
ClassificationNeurological Stereotaxic Instrument
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
ContactRanda Franklin
CorrespondentRanda Franklin
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-22
Decision Date2005-03-04
Summary:summary

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